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AMR Drug RepurposingSmart Screeningresearch prototype

Omaveloxolone

FDA-approved product (capsule, oral), marketed as Skyclarys.

Registered studies
25
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

Chemical structure of Omaveloxolone
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Friedreich ataxia

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other nervous system drugs
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA53.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli46.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae35.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis37.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

25registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Open Omaveloxolone in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.1 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.1 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-7.7 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.4 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Omaveloxolone with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies

    NCT06628687 · start 2026-10-26

    Registered record
    Registry ID
    NCT06628687
    Conditions
    Friedreich Ataxia
    Interventions
    Omaveloxolone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-10-26
    Completion
    2035-04-30
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFriedreich Ataxia
    InterventionOmaveloxolone
    PhaseNot recorded
    Registry statusRecruiting

  • Cardiac Output and Fatigue in Friedreich's Ataxia

    NCT07444333 · start 2026-04-01

    Registered record
    Registry ID
    NCT07444333
    Conditions
    Friedreich's Ataxia
    Interventions
    Aerobic Exercise; Omeveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2026-04-01
    Completion
    2028-04-01
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFriedreich's Ataxia
    InterventionAerobic Exercise; Omeveloxolone
    PhaseNot applicable
    Registry statusNot yet recruiting

  • A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55

    NCT07297199 · start 2025-12-12

    Registered record
    Registry ID
    NCT07297199
    Conditions
    Healthy Volunteer
    Interventions
    Omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2025-12-12
    Completion
    2026-05-01
    Enrolment
    70

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteer
    InterventionOmaveloxolone
    PhasePhase 1
    Registry statusCompleted

  • A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55

    NCT07149415 · start 2025-09-02

    Registered record
    Registry ID
    NCT07149415
    Conditions
    Healthy Volunteer
    Interventions
    Omaveloxolone; Omeprazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2025-09-02
    Completion
    2025-10-16
    Enrolment
    22

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteer
    InterventionOmaveloxolone; Omeprazole
    PhasePhase 1
    Registry statusCompleted

  • A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55

    NCT07019064 · start 2025-06-11

    Registered record
    Registry ID
    NCT07019064
    Conditions
    Healthy Volunteer
    Interventions
    Omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2025-06-11
    Completion
    2025-08-19
    Enrolment
    52

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteer
    InterventionOmaveloxolone
    PhasePhase 1
    Registry statusCompleted

  • A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia

    NCT06953583 · start 2025-06-09

    Registered record
    Registry ID
    NCT06953583
    Conditions
    Friedreich Ataxia
    Interventions
    Omaveloxolone; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2025-06-09
    Completion
    2029-11-22
    Enrolment
    255

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFriedreich Ataxia
    InterventionOmaveloxolone; Placebo
    PhasePhase 3
    Registry statusRecruiting

  • Efficacy of Omaveloxolone Treatment for Dysphagia in French Patients With Friedreich's Ataxia

    NCT07013292 · start 2025-06-01

    Registered record
    Registry ID
    NCT07013292
    Conditions
    Friedreich Ataxia
    Interventions
    SKYCLARYS (omaveloxolone)
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-06-01
    Completion
    2026-06-30
    Enrolment
    40

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFriedreich Ataxia
    InterventionSKYCLARYS (omaveloxolone)
    PhaseNot recorded
    Registry statusRecruiting

  • A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors

    NCT06623890 · start 2024-12-12

    Registered record
    Registry ID
    NCT06623890
    Conditions
    Friedreich Ataxia
    Interventions
    Omaveloxolone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-12-12
    Completion
    2029-10-01
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFriedreich Ataxia
    InterventionOmaveloxolone
    PhaseNot recorded
    Registry statusRecruiting

  • A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk

    NCT06612879 · start 2024-10-18

    Registered record
    Registry ID
    NCT06612879
    Conditions
    Healthy Volunteer
    Interventions
    Omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2024-10-18
    Completion
    2025-04-08
    Enrolment
    12

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteer
    InterventionOmaveloxolone
    PhasePhase 1
    Registry statusCompleted

  • A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

    NCT06054893 · start 2024-07-01

    Registered record
    Registry ID
    NCT06054893
    Conditions
    Friedreich Ataxia
    Interventions
    Omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2024-07-01
    Completion
    2030-06-04
    Enrolment
    33

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFriedreich Ataxia
    InterventionOmaveloxolone
    PhasePhase 1
    Registry statusActive not recruiting

  • A TQTc Study for Omaveloxolone

    NCT05927649 · start 2023-07-11

    Registered record
    Registry ID
    NCT05927649
    Conditions
    Health Adult Subjects
    Interventions
    Omaveloxolone; Moxifloxacin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2023-07-11
    Completion
    2023-09-01
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealth Adult Subjects
    InterventionOmaveloxolone; Moxifloxacin
    PhasePhase 1
    Registry statusCompleted

  • An Open-label DDI Study of Omaveloxolone in Healthy Subjects

    NCT05909644 · start 2023-07-05

    Registered record
    Registry ID
    NCT05909644
    Conditions
    Healthy Adult Subjects
    Interventions
    Omaveloxolone; Efavirenz
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2023-07-05
    Completion
    2023-08-30
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Adult Subjects
    InterventionOmaveloxolone; Efavirenz
    PhasePhase 1
    Registry statusCompleted

  • A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function

    NCT03902002 · start 2019-07-19

    Registered record
    Registry ID
    NCT03902002
    Conditions
    Hepatic Impairment
    Interventions
    Omaveloxolone 50 mg capsules
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-07-19
    Completion
    2020-01-27
    Enrolment
    48

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHepatic Impairment
    InterventionOmaveloxolone 50 mg capsules
    PhasePhase 1
    Registry statusCompleted

  • A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

    NCT04008186 · start 2019-06-14

    Registered record
    Registry ID
    NCT04008186
    Conditions
    Healthy Adult Subjects
    Interventions
    Omaveloxolone; Midazolam oral solution; Repaglinide 1 MG; MetFORMIN 500 Mg Oral Tablet; Rosuvastatin; Digoxin tablet; Gemfibrozil Tablets; Itraconazole capsule; Verapamil Pill
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-06-14
    Completion
    2019-08-28
    Enrolment
    61

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Adult Subjects
    InterventionOmaveloxolone; Midazolam oral solution; Repaglinide 1 MG; MetFORMIN 500 Mg Oral Tablet +5 more
    PhasePhase 1
    Registry statusCompleted

  • A Human AME Study for Omaveloxolone

    NCT03931590 · start 2019-04-11

    Registered record
    Registry ID
    NCT03931590
    Conditions
    Healthy Male Subjects
    Interventions
    [14C]-Omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-04-11
    Completion
    2019-05-31
    Enrolment
    8

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Male Subjects
    Intervention[14C]-Omaveloxolone
    PhasePhase 1
    Registry statusCompleted